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Anti-tumor antibiotic

Chemotherapy + Immunotherapy for Breast Cancer

Phase 1

Waitlist Available

Led By Sara Tolaney, MD MPH

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

The participant has an Eastern Cooperative Oncology Group (ECOG) performance status ≤1

Participants must have operable breast cancer, with tumors greater than or equal to 2 cm in size

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is studying how well chemotherapy and immunotherapy work in treating hormone receptor positive breast cancer.

Who is the study for?

This trial is for adults with hormone receptor-positive, HER2-negative operable breast cancer larger than 2 cm without distant metastasis. They must not have had prior treatments for this cancer and agree to use contraception. Participants need normal organ/marrow function, no active autoimmune diseases or infections, and can't be on systemic steroids/immunosuppressants.Check my eligibility

What is being tested?

The study tests chemotherapy (Nab-Paclitaxel) combined with immunotherapy (Pembrolizumab) in treating hormone receptor-positive breast cancer. It includes preoperative treatment and requires participants to undergo three research biopsies during the therapy.See study design

What are the potential side effects?

Possible side effects include reactions related to immune system activation such as inflammation of organs, infusion-related reactions, fatigue, blood disorders, increased risk of infection and potential allergic responses to the drugs' components.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active and can carry on all pre-disease activities without restriction.

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My breast cancer is operable and my tumor is at least 2 cm big.

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I have not had radiation on the same side breast before.

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I am 18 years old or older.

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I understand the study rules and have signed the consent form.

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My breast cancer is hormone receptor-positive and HER2-negative.

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I am willing to have three research biopsies during the study.

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My breast cancer diagnosis was confirmed through tissue examination.

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My cancer has not spread to distant parts of my body.

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I haven't received any treatment for my operable breast cancer.

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My organ and bone marrow functions are normal.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in PD-L1 Expression By Immunohistochemistry From Baseline Biopsy to Biopsy After 2-Week Treatment (biopsy 2)

Secondary outcome measures

Disease-Free Survival

Maximum Grade Of All Treatment-Related Adverse Events

Overall Response Rate

+4 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183

21%

Fatigue

13%

Nausea

11%

Back pain

Shortness of Breath

Anemia

Abdominal pain

Diarrhea

Pneumonia

Kidney Injury and/or Infection

Dyspnea

Weight Loss

Malnutrition, Hypercalcemia and Weakness

Pneumothorax

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Pleural effusion

Atrial fibrillation with rapid ventricular response

Thrombocytopenia

Respiratory failure

Skin rash

colitis

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

Trial Design

2Treatment groups

Experimental Treatment

Group I: PembrolizumabExperimental Treatment3 Interventions

2 weeks Pembrolizumab Run in Biopsy will be performed Post mono therapy Nab-Paclitaxel administered weekly Post mono therapy Pembrolizumab administered every 3 weeks Agents administered for a total of 14 weeks

Group II: Nab-PaclitaxelExperimental Treatment3 Interventions

2 weeks Nab-Paclitaxel Run in Biopsy will be performed Post mono therapy Nab-Paclitaxel administered weekly Post mono therapy Pembrolizumab administered every 3 weeks Agents administered for a total of 15 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nab-Paclitaxel

2014

Completed Phase 3

~4340

Biopsy

2014

Completed Phase 4

~1090

Pembrolizumab

2017

Completed Phase 2

~2010

0 / 11Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor

1,079 Previous Clinical Trials

340,898 Total Patients Enrolled

141 Trials studying Breast Cancer

22,567 Patients Enrolled for Breast Cancer

Adrienne G. WaksLead Sponsor

3 Previous Clinical Trials

203 Total Patients Enrolled

2 Trials studying Breast Cancer

163 Patients Enrolled for Breast Cancer

Merck Sharp & Dohme LLCIndustry Sponsor

3,887 Previous Clinical Trials

5,054,924 Total Patients Enrolled

58 Trials studying Breast Cancer

7,484 Patients Enrolled for Breast Cancer

Media Library

Nab-Paclitaxel (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT02999477 — Phase 1

Breast Cancer Research Study Groups: Nab-Paclitaxel, Pembrolizumab

Breast Cancer Clinical Trial 2023: Nab-Paclitaxel Highlights & Side Effects. Trial Name: NCT02999477 — Phase 1

Nab-Paclitaxel (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02999477 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does Pembrolizumab pose any substantial risks to patients?

"There is limited data affirming the safety of pembrolizumab, which led to it being given a score of 1."

Answered by AI

What is the cumulative enrollment for this experiment?

"At present, this medical trial is not actively seeking new participants. The first listing of the study was posted on February 23rd 2017 while the most recent update came in August 22nd 2022. For individuals looking for additional trials, there are currently 2600 studies recruiting patients with breast cancer and 1697 clinical tests accepting Pembrolizumab applicants."

Answered by AI

Are there opportunities to join this experiment at present?

"Unfortunately, this research is not currently seeking any participants. As posted by clinicaltrials.gov, the initial post was created on February 23rd 2017 and last edited on August 22nd 2022; however, there are 4297 other medical studies that are open for enrollment at present."

Answered by AI

What prior studies have been conducted to assess the efficacy of Pembrolizumab?

"Currently, there are 1697 clinical trials assessing the efficacy of pembrolizumab. Of those active studies, 323 have advanced to Phase 3. With 74578 locations across Shanghai conducting research on this therapy, it is clear that Pembrolimzumab has been extensively studied here."

Answered by AI

What medical conditions have been effectively treated with Pembrolizumab?

"Pembrolizumab is traditionally administered to patients with inoperable melanoma. Nevertheless, it has been identified as a potential treatment for multiple other malignancies including those with microsatellite instability-high (MSI-H) and high recurrence risk."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study Of Changes In PD-L1 Expression During Preoperative Treatment With Nab-Paclitaxel And Pembrolizumab In Hormone Receptor-Positive Breast Cancer

Adrienne G. Waks 2017. "A Study Of Changes In PD-L1 Expression During Preoperative Treatment With Nab-Paclitaxel And Pembrolizumab In Hormone Receptor-Positive Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02999477.

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